Spine Wave Inc

FDA Filings

This page includes the latest FDA filings for Spine Wave Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3004638600
• FEI Number: 3004638600
• Name: SPINE WAVE, INC.
• Owner & Operator: SPINE WAVE, INC.
• Contact Address: THREE ENTERPRISE DR. SUITE 210; Shelton CT 06484 US
• Official Correspondent:
  • RONALD K SMITH
  • x-203-9449494-340
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: THREE ENTERPRISE DR. SUITE 210; SHELTON, CT 06484 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GUDID 10840642154665 Spine Wave, Inc.	CapSure® Spine System 10-3034	2025-05-21
GUDID 10840642176612 Spine Wave, Inc.	Salvo® Robotic Navigation Instruments 10-8653	2025-05-09
GUDID 10840642175585 Spine Wave, Inc.	Salvo® Spine System 10-8688	2025-05-09
GUDID 10840642159424 Spine Wave, Inc.	Salvo® Spine System 10-8737	2025-02-28
GUDID 10840642159400 Spine Wave, Inc.	Salvo® Spine System 10-8735	2025-02-28
GUDID 10840642159714 Spine Wave, Inc.	Salvo® Spine System 10-8406	2025-02-04
GUDID 10840642159707 Spine Wave, Inc.	Salvo® Spine System 10-8405	2025-02-04
GUDID 10840642154504 Spine Wave, Inc.	Salvo® Spine System 10-8367	2025-02-04
GUDID 10840642154498 Spine Wave, Inc.	Salvo® Spine System 10-8366	2025-02-04
GUDID 10840642163247 Spine Wave, Inc.	Salvo® Spine System 10-8328	2025-02-03
GUDID 10840642162905 Spine Wave, Inc.	Salvo® Spine System 10-8429	2025-02-03
GUDID 10840642160024 Spine Wave, Inc.	Salvo® Spine System 10-8680	2025-02-03
GUDID 10840642159776 Spine Wave, Inc.	Salvo® Spine System 10-8426	2025-02-03
GUDID 10840642159769 Spine Wave, Inc.	Salvo® Spine System 10-8425	2025-02-03
GUDID 10840642159691 Spine Wave, Inc.	Salvo® Spine System 10-8404	2025-02-03
GUDID 10840642142211 Spine Wave, Inc.	Salvo® Spine System 10-8283	2025-02-03
GUDID 10840642142198 Spine Wave, Inc.	Salvo® Spine System 10-8279	2025-02-03
GUDID 10840642142174 Spine Wave, Inc.	Salvo® Spine System 10-8288	2025-02-03
GUDID 10840642142051 Spine Wave, Inc.	Salvo® Spine System 10-8284	2025-02-03
GUDID 10840642141672 Spine Wave, Inc.	Salvo® Spine System 10-8285	2025-02-03
GUDID 10840642168747 Spine Wave, Inc.	Salvo® Spine System 13-8240	2024-12-17
GUDID 10840642168471 Spine Wave, Inc.	Salvo® Spine System 13-8239	2024-12-17
GUDID 10840642166057 Spine Wave, Inc.	Salvo® Spine System 13-8238	2024-12-17
GUDID 10840642166040 Spine Wave, Inc.	Salvo® Spine System 13-8237	2024-12-17
GUDID 10840642166033 Spine Wave, Inc.	Salvo® Spine System 13-8236	2024-12-17
GUDID 10840642166026 Spine Wave, Inc.	Salvo® Spine System 13-8235	2024-12-17
GUDID 10840642166019 Spine Wave, Inc.	Salvo® Spine System 13-8234	2024-12-17
GUDID 10840642166002 Spine Wave, Inc.	Salvo® Spine System 13-8233	2024-12-17
GUDID 10840642165999 Spine Wave, Inc.	Salvo® Spine System 13-8232	2024-12-17
GUDID 10840642165982 Spine Wave, Inc.	Salvo® Spine System 13-8231	2024-12-17
GUDID 10840642165975 Spine Wave, Inc.	Salvo® Spine System 13-8230	2024-12-17
GUDID 10840642165968 Spine Wave, Inc.	Salvo® Spine System 13-8229	2024-12-17
GUDID 10840642165951 Spine Wave, Inc.	Salvo® Spine System 13-8228	2024-12-17
GUDID 10840642165944 Spine Wave, Inc.	Salvo® Spine System 13-8227	2024-12-17
GUDID 10840642165937 Spine Wave, Inc.	Salvo® Spine System 13-8226	2024-12-17
GUDID 10840642165906 Spine Wave, Inc.	Salvo® Spine System 13-8225	2024-12-17
GUDID 10840642166606 Spine Wave, Inc.	Salvo® Spine System 13-8219	2024-12-16
GUDID 10840642166590 Spine Wave, Inc.	Salvo® Spine System 13-8218	2024-12-16
GUDID 10840642166583 Spine Wave, Inc.	Salvo® Spine System 13-8217	2024-12-16
GUDID 10840642166576 Spine Wave, Inc.	Salvo® Spine System 13-8216	2024-12-16
GUDID 10840642166569 Spine Wave, Inc.	Salvo® Spine System 13-8215	2024-12-16
GUDID 10840642165890 Spine Wave, Inc.	Salvo® Spine System 13-8224	2024-12-16
GUDID 10840642165883 Spine Wave, Inc.	Salvo® Spine System 13-8223	2024-12-16
GUDID 10840642165869 Spine Wave, Inc.	Salvo® Spine System 13-8212	2024-12-16
GUDID 10840642165708 Spine Wave, Inc.	Salvo® Spine System 13-8207	2024-12-16
GUDID 10840642165692 Spine Wave, Inc.	Salvo® Spine System 13-8206	2024-12-16
GUDID 10840642165685 Spine Wave, Inc.	Salvo® Spine System 13-8205	2024-12-16
GUDID 10840642165463 Spine Wave, Inc.	Salvo® Spine System 13-8209	2024-12-16
GUDID 10840642165456 Spine Wave, Inc.	Salvo® Spine System 13-8208	2024-12-16
GUDID 10840642165449 Spine Wave, Inc.	Salvo® Spine System 13-8211	2024-12-16
GUDID 10840642165432 Spine Wave, Inc.	Salvo® Spine System 13-8210	2024-12-16
GUDID 10840642165425 Spine Wave, Inc.	Salvo® Spine System 13-8222	2024-12-16
GUDID 10840642165418 Spine Wave, Inc.	Salvo® Spine System 13-8214	2024-12-16
GUDID 10840642165401 Spine Wave, Inc.	Salvo® Spine System 13-8213	2024-12-16
GUDID 10840642165395 Spine Wave, Inc.	Salvo® Spine System 13-8195	2024-12-16
GUDID 10840642165388 Spine Wave, Inc.	Salvo® Spine System 13-8194	2024-12-16
GUDID 10840642165371 Spine Wave, Inc.	Salvo® Spine System 13-8193	2024-12-16
GUDID 10840642165364 Spine Wave, Inc.	Salvo® Spine System 13-8201	2024-12-16
GUDID 10840642165357 Spine Wave, Inc.	Salvo® Spine System 13-8200	2024-12-16
GUDID 10840642165340 Spine Wave, Inc.	Salvo® Spine System 13-8199	2024-12-16
GUDID 10840642165333 Spine Wave, Inc.	Salvo® Spine System 13-8221	2024-12-16
GUDID 10840642165326 Spine Wave, Inc.	Salvo® Spine System 13-8197	2024-12-16
GUDID 10840642165319 Spine Wave, Inc.	Salvo® Spine System 13-8196	2024-12-16
GUDID 10840642165302 Spine Wave, Inc.	Salvo® Spine System 13-8198	2024-12-16
GUDID 10840642165296 Spine Wave, Inc.	Salvo® Spine System 13-8203	2024-12-16
GUDID 10840642165289 Spine Wave, Inc.	Salvo® Spine System 13-8204	2024-12-16
GUDID 10840642165272 Spine Wave, Inc.	Salvo® Spine System 13-8202	2024-12-16
GUDID 10840642165265 Spine Wave, Inc.	Salvo® Spine System 13-8192	2024-12-16
GUDID 10840642165227 Spine Wave, Inc.	Salvo® Spine System 13-8191	2024-12-16
GUDID 10840642165210 Spine Wave, Inc.	Salvo® Spine System 13-8190	2024-12-16
GUDID 10840642149395 Spine Wave, Inc.	Salvo® Spine System 13-8174	2024-12-16
GUDID 10840642149388 Spine Wave, Inc.	Salvo® Spine System 13-8170	2024-12-16
GUDID 10840642149371 Spine Wave, Inc.	Salvo® Spine System 13-8169	2024-12-16
GUDID 10840642149364 Spine Wave, Inc.	Salvo® Spine System 13-8168	2024-12-16
GUDID 10840642149357 Spine Wave, Inc.	Salvo® Spine System 13-8167	2024-12-16
GUDID 10840642149340 Spine Wave, Inc.	Salvo® Spine System 13-8161	2024-12-16
GUDID 10840642149333 Spine Wave, Inc.	Salvo® Spine System 13-8160	2024-12-16
GUDID 10840642149326 Spine Wave, Inc.	Salvo® Spine System 13-8159	2024-12-16
GUDID 10840642149319 Spine Wave, Inc.	Salvo® Spine System 13-8158	2024-12-16
GUDID 10840642149302 Spine Wave, Inc.	Salvo® Spine System 13-8157	2024-12-16
GUDID 10840642149296 Spine Wave, Inc.	Salvo® Spine System 13-8156	2024-12-16
GUDID 10840642149289 Spine Wave, Inc.	Salvo® Spine System 13-8173	2024-12-16
GUDID 10840642149272 Spine Wave, Inc.	Salvo® Spine System 13-8172	2024-12-16
GUDID 10840642149258 Spine Wave, Inc.	Salvo® Spine System 13-8165	2024-12-16
GUDID 10840642149241 Spine Wave, Inc.	Salvo® Spine System 13-8164	2024-12-16
GUDID 10840642149234 Spine Wave, Inc.	Salvo® Spine System 13-8163	2024-12-16
GUDID 10840642149227 Spine Wave, Inc.	Salvo® Spine System 13-8162	2024-12-16
GUDID 10840642149210 Spine Wave, Inc.	Salvo® Spine System 13-8155	2024-12-16
GUDID 10840642149203 Spine Wave, Inc.	Salvo® Spine System 13-8154	2024-12-16
GUDID 10840642149197 Spine Wave, Inc.	Salvo® Spine System 13-8153	2024-12-16
GUDID 10840642149180 Spine Wave, Inc.	Salvo® Spine System 13-8152	2024-12-16
GUDID 10840642149173 Spine Wave, Inc.	Salvo® Spine System 13-8151	2024-12-16
GUDID 10840642149166 Spine Wave, Inc.	Salvo® Spine System 13-8150	2024-12-16
GUDID 10840642149135 Spine Wave, Inc.	Salvo® Spine System 13-8147	2024-12-16
GUDID 10840642149128 Spine Wave, Inc.	Salvo® Spine System 13-8146	2024-12-16
GUDID 10840642149111 Spine Wave, Inc.	Salvo® Spine System 13-8145	2024-12-16
GUDID 10840642149098 Spine Wave, Inc.	Salvo® Spine System 13-8143	2024-12-16
GUDID 10840642149050 Spine Wave, Inc.	Salvo® Spine System 13-8142	2024-12-16
GUDID 10840642148244 Spine Wave, Inc.	Salvo® Spine System 13-8141	2024-12-16
GUDID 10840642148237 Spine Wave, Inc.	Salvo® Spine System 13-8140	2024-12-16
PMN K202476 Spine Wave, Inc.	Salvo® Spine System	2020-11-05
PMN K192526 Spine Wave, Inc.	Spine Wave Navigated Instruments	2019-10-10
PMN K191045 | NKB SPINE WAVE, INC.	Salvo Spine System	2019-08-02
PMN K191045 Spine Wave, Inc.	Salvo™ Spine System	2019-07-10
PMN K182954 | NKB SPINE WAVE, INC.	Salvo Spine System	2019-01-02
PMN K182954 Spine Wave, Inc.	Salvo™ Spine System	2018-12-12
PMN K181596 | OLO SPINE WAVE, INC.	Spine Wave Navigated Instruments	2018-11-07
PMN K181596 Spine Wave, Inc.	Spine Wave Navigated Instruments	2018-10-24
PMN K181440 | NKG SPINE WAVE, INC.	Proficient Posterior Cervical Spine System	2018-08-15
PMN K181440 Spine Wave, Inc.	Proficient® Posterior Cervical Spine System	2018-07-30
GDZ SPINE WAVE, INC.	Scalpel Handle	2018-06-21
PMN K173175 | OVE SPINE WAVE, INC.	Paramount? Anterior Cervical Spine System	2018-06-07
PMN K172594 | NKG SPINE WAVE, INC.	Proficient? Posterior Cervical Spine System	2018-01-02
PMN K172594 Spine Wave, Inc.	Proficient® Posterior Cervical Spine System	2017-12-15
PMN K173175 Spine Wave, Inc.	Paramount Anterior Cervical Cage System	2017-11-01
PMN K172175 Spine Wave, Inc.	CapSure® PS System	2017-08-16
PMN K163246 | MAX SPINE WAVE, INC.	Leva(R) Anterior Expandable Spacer System	2017-04-10
PMN K163246 SPINE WAVE, INC.	Leva Anterior Expandable Spacer System	2017-04-06
PMN K162760 | OVE SPINE WAVE, INC.	Paramount? Anterior Cervical Spine System	2017-03-02
PMN K162639 | NKG SPINE WAVE, INC.	Proficient? Posterior Cervical Spine System	2017-02-20
PMN K162760 SPINE WAVE, INC.	Spine Wave Anterior Cervical Spine System	2017-02-16
PMN K162639 Spine Wave, Inc.	Proficient™ Posterior Cervical Spine System	2017-02-07
PMN K161993 | OVD SPINE WAVE, INC.	Leva? Anterior Interbody System	2016-11-28
PMN K161993 Spine Wave, Inc.	Leva® Anterior Interbody System	2016-11-22
PMN K160003 | MNI SPINE WAVE, INC.	Sniper? Spine System	2016-09-25
PMN K160003 | MNH SPINE WAVE, INC.	Sniper? Spine System	2016-09-25
PMN K153222 | MAX SPINE WAVE, INC.	Leva(R) Spacer System	2016-04-18
PMN K153222 SPINE WAVE, INC.	Leva Spacer System	2016-04-15
PMN K100743 | MAX SPINE WAVE, INC.	True Position? Pivoting Spacer System	2016-03-03
PMN K160003 SPINE WAVE, INC.	Sniper (R) Spine System	2016-02-26
PMN K152620 | MAX SPINE WAVE, INC.	Velocity? Expandable Interbody System	2016-02-03
PMN K152620 SPINE WAVE, INC.	Spine Wave Gen II Expandable Interbody System	2016-01-15
PMN K152174 | MNI SPINE WAVE, INC.	Sniper? Spine System	2015-11-13
PMN K152174 | MNH SPINE WAVE, INC.	Sniper? Spine System	2015-11-13
PMN K151813 | MNI SPINE WAVE, INC.	Sniper? Spine System	2015-11-13
PMN K151813 | MNH SPINE WAVE, INC.	Sniper? Spine System	2015-11-13
PMN K151581 | MAX SPINE WAVE, INC.	Leva? Spacer System	2015-11-13
PMN K150285 | MAX SPINE WAVE, INC.	Leva? Spacer System	2015-11-13
PMN K142996 | MQP SPINE WAVE, INC.	StaXx? XD System	2015-11-13
PMN K091926 | KWQ SPINE WAVE, INC.	Ni-Lock? Anterior Cervical Plate System	2015-10-23
PMN K091531 | ODP SPINE WAVE, INC.	Accent? Cervical Spacer System	2015-10-23
PMN K152174 SPINE WAVE, INC.	Sniper Spine System	2015-08-31
PMN K151813 SPINE WAVE, INC.	Sniper Spine System	2015-07-31
PMN K151581 SPINE WAVE, INC.	Leva Spacer System	2015-07-09
PMN K150285 SPINE WAVE, INC.	Leva(TM) Spacer System	2015-03-05
PMN K142996 SPINE WAVE, INC.	StaXx(R) XD System	2015-02-19
PMN K141980 | MAX SPINE WAVE, INC.	Leva(TM) Spacer System	2015-02-13
PMN K141980 SPINE WAVE, INC.	LEVA (TM) SPACER SYSTEM	2015-01-26
PMN K142980 SPINE WAVE, INC.	Proficient (TM) Facet Screw Spine System	2015-01-16
PMN K142101 SPINE WAVE, INC.	ABACUS (TM) SPACER SYSTEM	2014-10-23
PMN K140007 | MAX SPINE WAVE, INC.	Abacus Spacer System	2014-05-13
PMN K140007 SPINE WAVE, INC.	ABACUS TM SPACER SYSTEM	2014-04-07
PMN K132403 SPINE WAVE, INC.	ANNEXTM ADJACENT LEVEL SYSTEM	2014-01-10
PMN K133207 SPINE WAVE, INC.	STAXX(R) SYSTEM	2013-12-06
PMN K132719 SPINE WAVE, INC.	STAXX IBL SYSTEM	2013-10-04
PMN K131071 SPINE WAVE, INC.	STAXX IBL SYSTEM	2013-08-20
PMN K132154 SPINE WAVE, INC.	CAPSURE PS SYSTEM	2013-08-09
PMN K123461 SPINE WAVE, INC.	STAXX(R) IB SYSTEM	2013-04-11
PMN K122233 SPINE WAVE, INC.	CAPSURE(R) PS SYSTEM	2012-10-11
PMN K121889 SPINE WAVE, INC.	STAXX XD SYSTEM	2012-08-29
PMN K120646 SPINE WAVE, INC.	CAPSURE(R) PS SYSTEM	2012-06-07
PMN K111418 SPINE WAVE, INC.	STAXX(R) XD SYSTEM	2011-12-13
PMN K111913 SPINE WAVE, INC.	CAPSURE(R) PS SYSTEM	2011-08-31
PMN K102315 SPINE WAVE, INC.	STAXX XDL SYSTEM	2011-08-19
PMN K111469 SPINE WAVE, INC.	STAXXSD SYSTEM	2011-07-19
PMN K102682 | MQP SPINE WAVE, INC.	StaXx(R) XD System	2010-12-15
FDG SPINE WAVE, INC.	RETRACTOR	2010-12-15
PMN K102682 SPINE WAVE, INC.	STAXX(R) XD SYSTEM	2010-11-30
PMN K101288 | MQP SPINE WAVE, INC.	StaXx(R) XD System	2010-09-24
PMN K101288 SPINE WAVE, INC.	STAXX XD SYSTEM	2010-09-10
PMN K100605 | MNH SPINE WAVE, INC.	Sniper MIS System	2010-07-16
PMN K100605 SPINE WAVE, INC.	MIS SYSTEM	2010-06-04
PMN K100122 | MNI SPINE WAVE, INC.	CapSure(R) PS Spine System	2010-03-25
PMN K100122 | MNH SPINE WAVE, INC.	CapSure(R) PS Spine System	2010-03-25
PMN K100122 SPINE WAVE, INC.	MODIFICATION TO CAPSURE PS SYSTEM	2010-02-12
PMN K083743 | MNI SPINE WAVE, INC.	CapSure(R) PS System	2009-12-07
PMN K083743 | MNH SPINE WAVE, INC.	CapSure(R) PS System	2009-12-07
PMN K083353 | MNI SPINE WAVE, INC.	CapSure(R) PS System	2009-12-07
PMN K083353 | MNH SPINE WAVE, INC.	CapSure(R) PS System	2009-12-07
PMN K081228 | MNI SPINE WAVE, INC.	CapSure(R) PS System	2009-12-07
PMN K081228 | MNH SPINE WAVE, INC.	CapSure(R) PS System	2009-12-07
PMN K090315 SPINE WAVE, INC.	STAXX XD SYSTEM	2009-09-03
PMN K083743 SPINE WAVE, INC.	CAPSURE PS SYSTEM	2009-01-13
PMN K083353 SPINE WAVE, INC.	CAPSURE(R) PS SYSTEM	2008-12-11
PMN K081228 SPINE WAVE, INC.	CAPSURE PS (R) SPINE SYSTEM	2008-05-12
GEA SPINE WAVE, INC.	Funnels	2007-12-03
HTD SPINE WAVE, INC.	FORCEPS	2007-09-13
PMN K070245 | MNI SPINE WAVE, INC.	CAPSURE PS SPINE SYSTEM	2007-06-25
PMN K070245 | MNH SPINE WAVE, INC.	CAPSURE PS SPINE SYSTEM	2007-06-25
HXX SPINE WAVE, INC.	SCREWDRIVER	2007-06-25
HXX SPINE WAVE, INC.	CAP DRIVER	2007-06-25
HXW SPINE WAVE, INC.	ROD BENDER	2007-06-25
HXC SPINE WAVE, INC.	TORQUE WRENCH	2007-06-25
HXB SPINE WAVE, INC.	SOUNDING PROBE	2007-06-25
HXB SPINE WAVE, INC.	PEDICLE PROBE	2007-06-25
HWX SPINE WAVE, INC.	BONE TAP	2007-06-25
HWJ SPINE WAVE, INC.	AWL	2007-06-25
PMN K063606 SPINE WAVE, INC.	MODIFICATION TO STAXX FX SYSTEM	2007-04-13
PMN K070245 SPINE WAVE, INC.	CAPSURE PEDICLE SCREW SYSTEM	2007-04-05
MDM SPINE WAVE, INC.	MANUAL SURGICAL INSTRUMENTS	2006-07-12
LXH SPINE WAVE, INC.	SPREADER	2006-07-12
LXH SPINE WAVE, INC.	DISTRACTOR	2006-07-12
HTX SPINE WAVE, INC.	PITUITARY RONGEUR	2006-07-12
HTR SPINE WAVE, INC.	BONE RASP	2006-07-12
HTF SPINE WAVE, INC.	RING CURETTE	2006-07-12
GFI SPINE WAVE, INC.	OSTEOTOME	2006-07-12
GAD SPINE WAVE, INC.	NERVE ROOT RETRACTOR	2006-07-12
PMN K053336 SPINE WAVE, INC.	STAXX FX SYSTEM	2006-07-03
PMN K052670 SPINE WAVE, INC.	STAXX XD SYSTEM	2006-04-27
NBH SPINE WAVE, INC.	ARTHROSCOPIC INSTRUMENTS; MANUAL SURGICAL INSTRUMENTS	2004-07-01
HXI SPINE WAVE, INC.	GUIDE WIRE	2004-07-01
HXG SPINE WAVE, INC.	TAMP	2004-07-01
HWT SPINE WAVE, INC.	TEMPLATE	2004-07-01
HWB SPINE WAVE, INC.	PIN PULLER	2004-07-01
HWA SPINE WAVE, INC.	MALLET	2004-07-01
FSM SPINE WAVE, INC.	INSTRUMENT CASES	2004-07-01
PMN K033303 SPINE WAVE, INC.	WAFER SYSTEM	2004-06-24

Related Finance Registrations

NCAGE Code	4J5R5	SPINE WAVE, INC.
CAGE Code	4J5R5	SPINE WAVE, INC.
S.A.M. Registration	4J5R5 [67789763]	SPINE WAVE, INC.
SEC	0001269997	SPINE WAVE, INC of DELAWARE